Post-radiotherapy Rhinosinusitis in Children (PRRSC)

May 20, 2026 updated by: University Hospital, Lille

Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy

Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important.

Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time.

Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients.

The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population (called exposed) concerns all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024 in the pediatric surgery department of the Lille University Hospital.

The control population (called non-exposed) included children treated during the same period for a non-head neck mesenchymal malignant cancer

Description

Inclusion Criteria:

  • Study population: all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024
  • Control population: all patient under 1 years of age managed for non -head neck mesenchymal cancer between January 1, 2018 and December 31, 2024

Exclusion Criteria:

  • Patients with hematological tumors;
  • Patients with mucociliary pathologies or proven allergic rhinitis before the diagnosis of cancer
  • Patients who have required surgical treatment that has removed more than half of the sinus cavities
  • Tumor recurrence at the time of inclusion
  • Sinus surgery between the last radiological check-up and inclusion
  • Administrative reasons: inability to receive informed information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed patients
Other: SNOT 22 questionnaire
22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)
Non exposed patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)
Time Frame: >1 year to <4 years after the end of oncologic treatment
>1 year to <4 years after the end of oncologic treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of CRS in pediatric patients after head neck mesenchymal cancer management
Time Frame: 1 year after the end of the oncologic treatment
1 year after the end of the oncologic treatment
Correlation between SNOT 22 and clinical assessment by PADORES score
Time Frame: >1 year to <4 years after the end of oncologic treatment
>1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and clinical assessment by lund-kennedy score
Time Frame: >1 year to <4 years after the end of oncologic treatment
>1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and radiological assessment by Lund-Mackay score
Time Frame: >1 year to <4 years after the end of oncologic treatment
>1 year to <4 years after the end of oncologic treatment
Radiological evolution of CRS by Lund-Mackay score
Time Frame: >1 year to <4 years after the end of oncologic treatment
>1 year to <4 years after the end of oncologic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Centre Oscar Lambret

Investigators

  • Principal Investigator: Pierre Fayoux, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_0549
  • 2022-A00422-41 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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